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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, bone
510(k) Number K121589
Device Name BIOMET MICROFIXATION FACIAL PLATING SYSTEM
Original Applicant
BIOMET MICROFIXATION
1520 tradeport dr.
jacksonville,  FL  32218
Original Contact lauren jasper
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/11/2012
Decision Date 09/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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